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Volasertib Granted Breakthrough Designation for AML

The U.S. Food and Drug Administration has granted breakthrough therapy designation to volasertib for the treatment of patients with previously untreated acute myeloid leukemia who are ineligible for intensive remission induction therapy, and who are 65 or older. Volasertib is an investigational inhibitor of polo-like kinase (Plk).

The breakthrough therapy designation, enacted as part of the FDA's 2012 Safety and Innovation Act, was created to expedite the development and review time of a potential new drug for serious or life-threatening disease where early clinical evidence suggests the drug may demonstrate substantial improvement compared with existing therapies.

Common treatment for AML is intensive chemotherapy followed by maintenance chemotherapy, though many patients over age 65 (the average age of a patient with AML) are ineligible for the large chemotherapy doses. According to estimates from the American Cancer Society, there will be 14,590 new cases of AML diagnosed in the U.S. in 2013, and 10,370 deaths from the disease.

A Phase II study of 87 patients with newly diagnosed AML ineligible for intensive treatment, showed higher rates of objective response and event-free survival in patients receiving volasertib in combination with low-dose cytarabine (LDAC) compared with patients receiving LDAC alone. Those results were presented at the American Society of Hematology Annual Meeting in December (Abstract 411), and a Phase III trial was initiated in January to assess the safety and efficacy of the drug used in combination with LDAC in patients 65 and older. That trial is currently enrolling patients.

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